Clinical Trials
Clinical trials are voluntary research studies, conducted in people, that are
designed to answer specific questions about the safety and/or effectiveness
of drugs, vaccines, other therapies, or new ways of using existing treatments.
AIDS/HIV Clinical Trials
- FDA issues a letter to all IND-holders
of antiretrovirals in the development for HIV. The purpose is to encourage
sponsors to study their drug in heavily treated patient populations with limited
treatment options, and to collaborate with other drug sponsors to develop
therapeutic options. The letter clarifies the agency's position on combining
investigational drugs in clinical trials, and designing trials that include
treatment experienced populations. This letter was drafted in response
to discussions held with respresentatives of several community groups, at
the "Salvage Workshop" in Toronto, Canada, in May 1999.
- Expanded Access and Expedited Approval
of New Therapies Related to HIV/AIDS (January 1996)
- Enrollment of Women in HIV Clinical
Trials
An evaluation abstract of the proportion of women enrolled in federally and
privately sponsored clinical trials for HIV/AIDS therapies initiated between
1989-1994
- AIDSinfo
The National
Library of Medicine (part of NIH) maintains this interactive database that
can help you locate trials studying HIV/AIDS.
- What Is an
AIDS Clinical Trial?
The National Library of Medicine (part of NIH) provides
basic information about trials and questions to ask if you are considering
participating in a clinical trial. Also available in Spanish
Gender and Clinical Trials
- Enrollment of Women in HIV Clinical
Trials
An evaluation abstract of the proportion of women enrolled in federally and
privately sponsored clinical trials for HIV/AIDS therapies initiated between
1989-1994
- Equality In Clinical Trials, Drugs and
Gender, by Judith Levine Willis, September 1997
- Talk Paper: FDA Proposes Rule
on Women in Clinical Trials, September 23, 1997
- Investigational New Drug Applications;
Proposed Amendment to Clinical Hold Regulations for Products Intended for
Life-Threatening Diseases, September
24, 1997.
FDA proposed amendments to the provisions of its regulations governing investigational
new drug applications (IND's) to permit FDA to place a clinical hold on one
or more studies under an IND involving a drug that is intended to treat a
life-threatening disease affecting both genders and are otherwise eligible
but are excluded from participation in an investigation only because of a
risk or potential risk of reproductive or developmental toxicity from use
of the investigational drug.
- Investigational New Drug Applications; Final Rule Amendment
to Clinical Hold Regulations for Products Intended for Life-Threatening Diseases
and Conditions
The Food and Drug Administration (FDA) amended the regulations governing investigational
new drug applications (IND's) to permit FDA to place a clinical hold on one
or more studies under an IND involving a drug that is intended to treat a
life-threatening disease or condition affecting both genders. The amendments
permit the agency to place a clinical hold on such studies if men or women
with reproductive potential who have the disease or condition are otherwise
eligible but are categorically excluded from participation solely because
of a perceived risk or potential risk of reproductive or developmental toxicity
from use of the investigational drug. This rule was developed in response
to the past practice of excluding women with reproductive potential from early
clinical trials because of a perceived risk or potential risk of reproductive
or developmental toxicity. The final rule does not impose requirements to
enroll or recruit a specific number of men or women with reproductive potential.
Information on Other Government Web Sites
- ClinicalTrials.gov: The National
Library of Medicine (part of NIH) maintains this interactive database that
can help you locate clinical trials for serious illnesses.
- ClinicalStudyResults.org:
A central, widely accessible, web-based repository for clinical study results
in a reader-friendly, standardized format.
- AIDSinfo: The National
Library of Medicine (part of NIH) maintains this interactive database that
can help you locate trials studying HIV/AIDS.
- What is an
AIDS Clinical Trial? The National Library of Medicine (part of NIH) provides
basic information about trials and questions to ask if you are considering
participating in a clinical trial. Also available in Spanish